Hypoallergenic

This article applies to all cosmetics sold in the United States.

Since the mid-1950’s “hypoallergenic” has been a buzz-word for describing cosmetic products. The dictionary definition for hypoallergenic is “having little tendency to cause an allergic reaction” or “specially prepared or treated so as to cause no reaction in persons allergic to the normal product.”¹

If you claim that your cosmetic product is hypoallergenic, you are claiming that it is less likely or unlikely to cause an allergic reaction than a similar product or a normal product in that category. It may have marketing benefit, but per the FDA, dermatologists say it has very little meaning.

From the legal point of view, there is no official FDA definition for hypoallergenic when it is applied to cosmetic products or labeling. They tried in 1974, but the DC Appeals Court found regulation to be invalid. Now the FDA says that it means whatever a particular company wants it to mean.²

So, can you claim a cosmetic product is “hypoallergenic”? Yes.

The Historical Details

The FDA published a proposed rule in 1974 to govern claims that a product was “hypoallergenic.” The rule included a requirement that there must be scientific studies that showed that the frequency of adverse reactions for the product was significantly less than the frequency of adverse reactions in a reference (similar) product.

The final regulation was published in 1975 and was included in the Code of Federal Regulations at 21 CFR § 700.100. The final rule reduced the testing required, but included a requirement that the claim of “hypoallergenic” on the label must be followed by the words, “Less likely to cause adverse reactions than some competing products.”

Within a month of the final rule being issued, Almay and Clinique brought suit in the US District Court for the District of Columbia, claiming that the regulation was arbitrary, capricious, and not in accordance with the law. The FDA filed for a motion of summary judgment, which was granted, and the case was thrown out.

Almay and Clinique filed an appeal. The final decision of US Court of Appeals for the District of Columbia was that the regulation was invalid. The regulation was removed from the Code of Federal Regulations. As a result of that ruling, manufacturers may label and advertise their cosmetics as “hypoallergenic” or make similar claims without any supporting evidence.

Hence the current stance of the FDA is that hypoallergenic means whatever a particular company wants it to mean.